NCT06832436

Brief Summary

Septic shock is a critical condition associated with high mortality. Transthoracic echocardiography is widely used to evaluate cardiac function and guide treatment. Left and right atrial strain (LAS and RAS) measured via speckle tracking echocardiography have shown prognostic value in cardiovascular diseases. However, differences exist between echocardiographic software, leading to challenges in result comparability. This study aims to compare LAS and RAS measurements between ECHOPAC and UWS software, evaluate AutoStrain technology, and assess reproducibility across observers. The study is non-interventional and will use retrospective echocardiographic data from patients treated for septic shock. The findings will contribute to improving measurement standardization in critically ill patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Mar 2025Sep 2026

First Submitted

Initial submission to the registry

February 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

March 6, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

February 11, 2025

Last Update Submit

January 15, 2026

Conditions

Keywords

transthoracic echocardiographyseptic shockleft atrial strainright atrial strainspeckle trackingechocardiographic softwareAutoStrainBland-Altman analysisreproducibilitycritical care

Outcome Measures

Primary Outcomes (1)

  • variation of LASr between ECOPAC and UWS

    Agreement of LAS Reservoir Phase (LASr) measurement in manual mode between ECHOPAC and UWS

    1 year

Secondary Outcomes (20)

  • variation of LAScd between ECHOPAC and UWS

    1 year

  • variation of LASct between ECHOPAC and UWS

    1 year

  • Comparison of LASr measurements in apical 2-chamber views

    1 year

  • Comparison of LAScd measurements in apical 2-chamber views

    1 year

  • Comparison of LASct measurements in apical 2-chamber views

    1 year

  • +15 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to critical care for septic shock (SEPSIS-3 definition)

You may qualify if:

  • Age: \>18 years
  • Adult patients admitted to critical care for septic shock (SEPSIS-3 definition)
  • TTE performed as part of medical management
  • No objection to data usage

You may not qualify if:

  • Pregnancy
  • Moderate to severe valvular regurgitation/stenosis (\>grade 2)
  • Ventricular or supraventricular tachyarrhythmia (HR \>140 bpm) at the time of TTE
  • Poor echogenicity preventing LAS measurement
  • Mechanical circulatory support
  • Pacemaker dependence
  • Patients under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Amiens

Salouël, 80480, France

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 18, 2025

Study Start

March 6, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations